510(k) K121256 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
ALCO-SCREEN 02
| Applicant | Chematics, Inc., North Webster IN, US |
| Decision | Substantially Equivalent, Sep 12, 2012 |
| Received | Apr 25, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121256
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.